The discovery and development of new drugs and medical innovations is often times a long (10-15 years) and costly process (1.5-2 billion dollars). Specifically, drugs must undergo a rigorous multi-phase clinical trial process, lasting several years (6-7 years), in which the effects of a drug are studied in volunteer patient populations. For instance, Phase-I trials may involve 20-100 volunteers, Phase-II trials may involve 100-500 volunteers, and Phase-III trials may involve 1000-5000 volunteers. In conducting such trials, trial coordinators often look to see if volunteers match certain sponsor defined criteria, and if so the patient is enrolled in a randomization study.
This screening process, however, is relatively limited, and a significant number of adverse events are nevertheless experienced in clinical trials, with over 3 million adverse drug reactions and 1 million deaths reported annually. The occurrence of adverse events may operate to extend the length of the trial and result in increased costs, and may be responsible, in part, for the high rate of clinical attrition, with a 40-45% failure rate experienced in Phase-III trials—where most of the failures are attributed to lack of sufficient efficacy and safety data. The clinical trial process is further complicated by the need for patient monitoring, which is generally performed during doctor visits to the study or testing site. However, such methods are not well suited for serious adverse events, which may require immediate medical attention.
Accordingly, a need exists for a remote monitoring tool that provides for early and targeted stratification of patients, which may result in improved drug success rates, increased drug response predictability, and improved identification of causal links between drug treatments and adverse events.